Инструкция по применению DONEPETSIL MYLAN JENERIKS ITALIA
Содержание инструкции
Donepezil Mylan Generics Italia 5 mg orodispersible tablets, 10 mg orodispersible tablets
donepezil hydrochloride
Equivalent Medicine
because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Donepezil Mylan Generics Italia is and what it is used for
- 2. What you need to know before you take Donepezil Mylan Generics Italia
- 3. How to take Donepezil Mylan Generics Italia
- 4. Possible side effects
- 5. How to store Donepezil Mylan Generics Italia
- 6. Contents of the pack and other information
1. What is Donepezil Mylan Generics Italia and what it is used for
Donepezil Mylan Generics Italia contains the active substance donepezil hydrochloride.
Donepezil hydrochloride belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil hydrochloride increases the levels in the brain of a substance
(acetylcholine) involved in memory function by slowing down its degradation.
This medicine is used to treat the symptoms of dementia in people who have been diagnosed with mild to moderate Alzheimer's disease. The symptoms
include increased memory loss, confusion and changes in
behaviour. As a result, people affected by Alzheimer's find it increasingly
difficult to perform normal daily activities.
It should only be used in adult patients.
2. What you need to know before taking Donepezil Mylan Generics Italia
Do not take Donepezil Mylan Generics Italia:
- If you are allergic to donepezil, piperidine derivatives (your doctor or pharmacist can advise you about this) or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions:
Talk to your doctor or pharmacist before taking Donepezil Mylan Generics Italia if
you suffer from or have ever suffered from any of the following conditions.
- A heart or rhythm disorder (especially an irregular heartbeat, or other conditions that affect the heartbeat or rhythm).
- Stomach or duodenal ulcers (intestine)
- Difficulty urinating
- Convulsions or epileptic seizures
- Stiffness, tremor or uncontrolled movements, especially of the face and tongue, but also of the limbs (which may have occurred after taking certain medications and are called “extrapyramidal” or Parkinson-like effects)
- Asthma or other long-term lung problems
- Liver problems.
Children and adolescents
Children and adolescents under 18 years of age should not take this medicine.
Other medicines and Donepezil Mylan Generics Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, especially if you are taking any of the following:
- other medicines for Alzheimer's disease, for example galantamine
- anticholinergics (which cause typical side effects of these medicines such as dry mouth, blurred vision and/or drowsiness) for example tolterodine (used for bladder problems)
- Antidepressants (e.g. fluoxetine)
- Erythromycin (an antibiotic)
- Rifampicin (for the treatment of tuberculosis)
- Antifungal medicines such as ketoconazole, itraconazole
- Carbamazepine or phenytoin (for controlling epilepsy)
- Medicines for heart disorders such as quinidine, beta-blockers (e.g. propranolol and atenolol)
- Painkillers or treatments for arthritis such as acetylsalicylic acid (“aspirin”), non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac
- Muscle relaxants such as diazepam
If you need to undergo surgery, including dental surgery, requiring the use
of an anesthetic, tell your doctor, dentist, hospital staff or anesthesiologist that
you are taking this medicine.
Donepezil Mylan Generics Italia with alcohol
Be particularly careful when using alcohol when taking this medicine because
alcohol can reduce the effect of donepezil hydrochloride.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask
for advice from your doctor before taking this medicine.
Donepezil hydrochloride should not be used during pregnancy unless clearly necessary.
Women taking this medicine should not breastfeed.
Driving and using machines
Do not drive vehicles or use machines if you feel dizzy or drowsy/tired or if you
experience muscle cramps during treatment with this medicine.
Alzheimer's disease can also alter your ability to drive or use
machines and you should not perform these activities unless your doctor has told you that
you can do so safely.
Donepezil Mylan Generics Italia contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e.
essentially “sodium-free”.
3. How to take Donepezil Mylan Generics Italia
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Tell your doctor the name of the person who assists you. This person will help you to take
the medicine as it has been prescribed for you.
Adults
The usual recommended starting dose is 5 mg taken once a day, usually in the
evening before going to bed, for at least one month.
After one month, your doctor may then increase the dose to 10 mg once a day, usually
in the evening before going to bed.
The maximum daily dose is 10 mg per day.
The tablet should be held on the tongue until completely disintegrated before
swallowing with or without water, depending on the patient's preference. You can take
this medicine with or without food.
Your doctor will tell you how long you need to continue taking these tablets.
You should see your doctor regularly to review the treatment and assess your
symptoms
Use in patients with hepatic and renal impairment
In adults with mild to moderate liver problems, your doctor may want to change the
dose.
Normally, no dose adjustment is required if you suffer from kidney problems.
If you take more Donepezil Mylan Generics Italia than you should
Do not take more than one tablet a day. Contact your doctor or the
Emergency Room of the nearest hospital immediately if you have taken more tablets than you should. Bring
with you the box and the remaining tablets to the hospital so that the doctor knows what
you have taken.
The symptoms of overdose include: feeling and state of unwellness, salivation,
sweating, slowing of the heartbeat, lowering of blood pressure
(slight dizziness or vertigo when standing up), difficulty breathing, fainting, seizures or convulsions and muscle weakness.
If you forget to take Donepezil Mylan Generics Italia
If you have forgotten to take your tablet, take one tablet the next day
at the usual time.
Do not take a double dose to make up for a missed dose. If you forget to
take the medicine for more than one week, contact your doctor before taking
the medicine again.
If you stop taking Donepezil Mylan Generics Italia
When treatment is stopped, the beneficial effects of Donepezil Mylan Generics
Italia will gradually decrease.
Do not stop taking the tablets without talking to your doctor first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Immediately inform your doctor or go to the nearest hospital emergency room if you experience any of the following serious side effects:
Not common(may affect up to 1 in 100 people):
- bleeding of the stomach, liver or intestines, or ulcers of the stomach or duodenum (small intestine). If you vomit, you may see fresh blood or vomit that looks like coffee grounds, or you may have black, tarry stools or visible blood from the rectum (back passage)
- seizures.
Rare(may affect up to 1 in 1000 people):
- liver problems including hepatitis (inflammation of the liver). You may notice dark urine, pale stools, yellowing of the skin and the whites of the eyes (jaundice), feeling unwell and fever;
- changes in heart rhythm or a very slow heart rate.
Very rare(may affect up to 1 in 10,000 people):
- fever with muscle stiffness, sweating or a reduced level of consciousness (a condition called “Neuroleptic Malignant Syndrome”);
- Muscle weakness, tenderness or pain, especially if, at the same time, you feel unwell, have a high fever or dark urine. These symptoms may be caused by an abnormal muscle breakdown which can be life-threatening and can lead to kidney problems (a condition called rhabdomyolysis)
Other side effects include:
Very common(may affect more than 1 in 10 patients):
- diarrhoea,
- feeling sick (nausea),
- headache.
Common(may affect less than 1 in 10 patients):
- malaise,
- muscle cramps,
- feeling tired,
- insomnia (difficulty sleeping),
- cold,
- anorexia (loss of appetite),
- hallucinations (seeing or hearing things that are not real),
- unusual dreams including nightmares, agitation,
- aggressive behaviour,
- fainting,
- dizziness,
- abdominal pain or discomfort,
- skin rash or itching,
- uncontrolled urination,
- pain,
- accidents (the risk of falls and accidental injuries may increase).
Not common(may affect less than 1 in 100 patients):
- slowing of the heartbeat,
- an increase in the levels in the blood of a substance called creatine kinase, which is involved in metabolism and can be detected by blood tests.
- increased salivation in the mouth.
Rare(may affect less than 1 in 1000 patients):
- stiffness, tremor or uncontrolled movements especially of the face and tongue, but also of the limbs.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store Donepezil Mylan Generics Italia
- Keep this medicine out of the sight and reach of children .
- This medicine does not require special storage conditions.
- Do not use this medicine after the expiry date which is stated on the packaging and on the blister after Exp. The expiry date refers to the last day of that month.
- Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Donepezil Mylan Generics Italia contains
- The active substance is donepezil hydrochloride.
- Donepezil Mylan Generics Italia 5 mg orodispersible tablets: each tablet contains 5 mg of donepezil hydrochloride (equivalent to 4.56 mg of donepezil)
- Donepezil Mylan Generics Italia 10 mg orodispersible tablets: each tablet contains 10 mg of donepezil hydrochloride (equivalent to 9.12 mg of donepezil)
The other ingredients are mannitol (E421), anhydrous colloidal silica, hydroxypropylcellulose,
acesulfame potassium, glycine, sodium starch glycolate, crospovidone, microcrystalline
cellulose and magnesium stearate.
Donepezil Mylan Generics Italia 10 mg orodispersible tablets also contain
yellow iron oxide (E172).
Description of the appearance of Donepezil Mylan Generics Italia and package contents
Your medicine is in the form of orodispersible tablets.
Donepezil Mylan Generics Italia 5 mg appears as white, round tablets, with
beveled edges, with “DL 5” imprinted on one side and “M” on the other.
Donepezil Mylan Generics Italia 10 mg appears as yellow, round tablets, with
beveled edges, with “DL 10” imprinted on one side and “M” on the other.
Donepezil Mylan Generics Italia is available in blisters of 7, 10, 14, 28, 30, 50, 56, 60, 84,
98, 100, 120 and 180 orodispersible tablets.
Not all pack sizes may be marketed.
Marketing authorisation holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Manufacturer
McDermott Laboratories Ltd. T/A Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland
Mylan Hungary Kft., H-2900, Komárom, Mylan utca.1, Hungary
This medicinal product is authorised in the Member States of the European Economic Area
under the following denominations:
Italy Donepezil Mylan Generics Italia, 5 mg & 10 mg orodispersible tablets
Sweden Donezil

- Страна регистрации
- Форма выпускаOrodispersible tablet, 5 MG
- Код АТХN06DA02
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги DONEPETSIL MYLAN JENERIKS ITALIAФорма выпуска: Film-coated tablet, 5MGДействующее вещество: ДонепезилПроизводитель: TECNIGEN S.R.L.Отпускается по рецептуФорма выпуска: Film-coated tablet, 5 MGДействующее вещество: ДонепезилПроизводитель: ALMUS S.R.L.Отпускается по рецептуФорма выпуска: Film-coated tablet, 5 MGДействующее вещество: ДонепезилПроизводитель: LABORATORI ALTER S.R.L.Отпускается по рецепту
Аналоги DONEPETSIL MYLAN JENERIKS ITALIA в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог DONEPETSIL MYLAN JENERIKS ITALIA в Испания
Аналог DONEPETSIL MYLAN JENERIKS ITALIA в Польша
Аналог DONEPETSIL MYLAN JENERIKS ITALIA в Украина
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Часто задаваемые вопросы
DONEPETSIL MYLAN JENERIKS ITALIA требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество DONEPETSIL MYLAN JENERIKS ITALIA — Донепезил. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
DONEPETSIL MYLAN JENERIKS ITALIA производится компанией MYLAN S.P.A.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения DONEPETSIL MYLAN JENERIKS ITALIA с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить DONEPETSIL MYLAN JENERIKS ITALIA в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
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Другие лекарства с тем же действующим веществом (Донепезил) включают BLIXIE, DONEPETSIL ALMUS, DONEPETSIL ALTER. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















